QC SCIENTIST
Axelon
Warren NJ 07059 US
Job Description: Assistant QC Scientist
Onsite role, Warren NJ
Work Schedule: Mon - Fri, 8AM - 4:30PM EST
Purpose:
The QC Analyst is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial products. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, this position will be able to assist with training and assay transfer.
Required Competencies: Knowledge, Skills, and Abilities
- Hands-on experience with various bioanalytical techniques including ELISA, qPCR and FACS and cell-based
assays.
- Experience in assay transfer, technology transfer, validation from Analytical Developmental group to Quality
Control group.
- Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP
requirements.
- Technical writing skills.
- Problem-solving ability/mentality, technically adept and logical.
- Ability to represent the interests of the group on cross-functional teams.
- Ability to set priorities of the group and manage timelines.
- Ability to work with management locally and globally.
- Ability to communicate effectively with peers, department management and cross-functional peers.
Duties and Responsibilities
- Perform testing of in-process, final product, stability samples, and method transfer.
- Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
- Anticipate and troubleshoot problems.
- Recommend corrective actions and participate in the development of best practices.
- Understanding of regulatory guidelines.
- Complete all work in a timely manner.
- Work and communicate effectively within the team to ensure timelines are met.
- Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
- Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and
corrections required.
- Document training per procedural and cGMP requirements.
- Perform assigned tasks within a CAPA, deviation, or project
- Draft and review technical documents, such as SOPs and forms.
- Communicate effectively with management regarding task completion, roadblocks, and needs.
- Performs other tasks as assigned.
Education and Experience
- Bachelor’s degree required, preferably in Science.
- 2-3 years of relevant work experience, preferably in a regulated environment.
- An equivalent combination of education and experience may substitute. EX: if the person has a Master degree but
less exp. (1-2 years), manager would still consider that candidate.
Working Conditions
- The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is
required.
- The incumbent must analyze numerical values on a daily basis.
- The incumbent will be working a laboratory setting up to six (6) hours per day.
- The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per
day.
Additional Job Requirements:
Lab w/o blood & animal
Position Handles Hazardous Materials
Onsite role, Warren NJ
Work Schedule: Mon - Fri, 8AM - 4:30PM EST
Purpose:
The QC Analyst is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial products. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, this position will be able to assist with training and assay transfer.
Required Competencies: Knowledge, Skills, and Abilities
- Hands-on experience with various bioanalytical techniques including ELISA, qPCR and FACS and cell-based
assays.
- Experience in assay transfer, technology transfer, validation from Analytical Developmental group to Quality
Control group.
- Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP
requirements.
- Technical writing skills.
- Problem-solving ability/mentality, technically adept and logical.
- Ability to represent the interests of the group on cross-functional teams.
- Ability to set priorities of the group and manage timelines.
- Ability to work with management locally and globally.
- Ability to communicate effectively with peers, department management and cross-functional peers.
Duties and Responsibilities
- Perform testing of in-process, final product, stability samples, and method transfer.
- Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
- Anticipate and troubleshoot problems.
- Recommend corrective actions and participate in the development of best practices.
- Understanding of regulatory guidelines.
- Complete all work in a timely manner.
- Work and communicate effectively within the team to ensure timelines are met.
- Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
- Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and
corrections required.
- Document training per procedural and cGMP requirements.
- Perform assigned tasks within a CAPA, deviation, or project
- Draft and review technical documents, such as SOPs and forms.
- Communicate effectively with management regarding task completion, roadblocks, and needs.
- Performs other tasks as assigned.
Education and Experience
- Bachelor’s degree required, preferably in Science.
- 2-3 years of relevant work experience, preferably in a regulated environment.
- An equivalent combination of education and experience may substitute. EX: if the person has a Master degree but
less exp. (1-2 years), manager would still consider that candidate.
Working Conditions
- The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is
required.
- The incumbent must analyze numerical values on a daily basis.
- The incumbent will be working a laboratory setting up to six (6) hours per day.
- The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per
day.
Additional Job Requirements:
Lab w/o blood & animal
Position Handles Hazardous Materials